Senior Quality Assurance Specialist

3 weeks ago


Durham, North Carolina, United States KBI BioPharma Full time

Job Summary

This Quality Assurance Specialist position collaborates with cross-functional teams to ensure completion of Root Cause Analysis, CAPAs, and Effectiveness Checks for Deviations according to cGMP requirements and company SOP.

  • Reviews and approves Deviations, CAPAs, and ECs, providing support for timely review of events for classification, initiation in EtQ, and closure.
  • Facilitates external client review and resolution of client comments for assigned Deviations and CAPAs.
  • Mentors junior QA staff in Deviation/CAPA review and approval, including training and certification of QA approvers.
  • Provides metrics to management as requested.

Key Responsibilities

  • Works directly with Manufacturing, QA, and other departments responsible for GMP activities to resolve production-related Deviations and compliance issues in a timely manner.
  • Reviews and approves Deviations and CAPAs, providing support for batch release activities.
  • Collaborates with functional areas to improve the Deviation/CAPA system, including support in development of training materials and training personnel.
  • Supports the generation of metrics, trends, and project-specific status updates of Deviations and CAPAs.

Requirements

  • Minimum BS in a scientific field with 14+ years' experience or MS and 11+ years' experience in a QA cGMP regulated environment within Biopharmaceuticals or equivalent.
  • Experience with Quality Systems, including Batch Record review, supporting investigations, and CAPAs.
  • Knowledge of US, EU, and ROW cGMP guidelines required.


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